��ࡱ� > �� � � ���� � � ���������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������� � �� � bjbj���� 7� �� �� W �� �� �� � � � � � � � � ���� � � � 8 $ 5 � �) . I I I I I � � � �( �( �( �( �( �( �( �* � q- � �( i � � } } � � �( � � I I 4 [) ( ( ( � X � I � I �( ( � �( ( ( ( I ���� ���� � � & p ( �( q) 0 �) ( g. � L g. ( ( g. � $( � � L � 6 ( 3 , _ o � � � �( �( �! . � � � �) � � � � ���� ���� ���� ���� ���� ���� ���� ���� ���� ���� ���� ���� ���� ���� ���� ���� ���� g. � � � � � � � � � � � : Reviewer Name:Protocol Number:Reviewed From Date to Date:Date of Review:Subject Number:Number of visits reviewed:Instructions: This chart QA Tool will be used for the review of Source Documentation and Protocol for agreement. Check the appropriate boxes for each question listed in Section I. If more than one visit, indicate the # of visits with �Yes� and # of �No� per indicator in the appropriate column. Any issues and resolutions noted within Section I �Comments� will be summarized in Section II including Source Documentation Date, Date Resolved, and the name of the individual responsible for resolution. When the review and any resolutions are completed, this chart QA tool will be signed and dated by the QA Reviewer and filed within the Quality Management binder. Note: Other indicators or criteria may be added as determined by site staff. SECTION I - INDICATORS AND CRITERIAIndicator(s)CriteriaYES " N O " N / A " C o m m e n t s I n f o r m e d C o n s e n t a n d A s s e n t P r o c e s s a n d D o c u m e n t a t i o n I s i t d o c u m e n t e d t h a t t h e s t u d y h a s b e e n e x p l a i n e d t o t h e p a r t i c i p a n t a n d / o r l e g a l l y a u t h o r i z e d r e p r e s e n t a t i v e a l l o w i n g f o r t h e o p p o r t u n i t y t o a s k q u e s t i o n s ? A C u r r e n t v alid and approved version of the Informed Consent and/or Assent Form has been signed and dated in ink by participant or legally authorized representative? The participant signed and dated the Informed Consent, prior to study-specific procedures?Eligibility Criteria Has the participant met all Inclusion Criteria and Exclusion Criteria for the study? Has a chart note or eligibility checklist that addresses each specific criterion been completed & signed? Has the note or checklist been signed, credentialed, and dated by the clinician (or Investigator) responsible for enrolling the study subject? Prohibited/ Concomitant Medications Documentation of concomitant medications is complete with start/stops times and consistent with protocol?Is participant taking any prohibited medications? If yes, was this finding documented and the PI notified? Must ck protocol � N/A if no prohibited med. SECTION I - INDICATORS AND CRITERIA (cont.)Indicator(s)CriteriaYES " N O " N / A " C o m m e n t s S t u d y D r u g A d m i n i s t r a t i o n P r o c e s s e s H a s s t u d y d r u g b e e n a d m i n i s t e r e d p e r p r o t o c o l / S O P a n d d o c u m e n t e d a c c o r d i n g l y ? N o t e : T h i s i n c l u d e s a r e v i e w o f t h e d o c u m e n t a t i o n s u p p o r t i n g d o u b l e - c h e c k i n g o f m e d i c a t i o n s a s i n d i c a t e d . S t a r t and stop times recorded at appropriate timeframes with appropriate follow-up and documentation? (if applicable)Study Device Use/Implantation ProcessesHas study device been used or implanted per protocol/SOP and documented accordingly? Adverse Event (AE), and/or Serious Adverse Event (SAE) Identification and Reporting AEs and SAEs identified, recorded, and reported properly and according to CRU policy?Are there any AEs unreported? Are there any SAEs unreported? Missed Visits and Follow-up Has the participant missed any visits?If yes, are they documented according to the protocol and institutional requirements? Is there documentation of attempts to contact the participant noted? (i.e. Phone call, certified mail, etc.)Missed Tests/Procedures Have all protocol-required lab tests and procedures been performed?If no, have the missed tests/procedures been reported as Protocol Deviations?Treatment/Study Discontinuation If the participant has discon t i n u e d t r e a t m e n t o r s t u d y , h a v e a l l p r o t o c o l - r e q u i r e d s t e p s b e e n f o l l o w e d ? S E C T I O N I - I N D I C A T O R S A N D C R I T E R I A ( c o n t . ) I n d i c a t o r ( s ) C r i t e r i a Y E S " N O " N / A " C o m m e n t s M i s c e l l a n e o u s A r e a l l s o u r c e d o c u m e n t s l a b e l e d w i t h p a r t i c i p a n t I D ? 24 hour contact information given to subject. Data from source document matches CRF or database record for the visit?Are all entries signed and dated? Are all error corrections clear (strikethrough, initial and date)?All diagnostic tests ordered have corresponding results in the chart according to the protocol.Physician notes are written to document exams or procedures done. SECTION II � ISSUES AND RESOLUTIONS # 6 > @ A B f � � � � � $ ( � � . � � � � � � � � � � � � � u v � � ~ � � � � � ���������������¾������������������������������� hK � CJ aJ h�� hK � 5�\� h�, h�]� hK � hK � 6�\� h�� hK � 6�\� h�� hK � 6�CJ aJ hK � hMDP h�� hMDP 5�hMDP 6�CJ OJ QJ ^J aJ h�� hMDP 6�CJ OJ QJ ]� #h�� hMDP 6�CJ OJ QJ ^J aJ 0 # $ @ A � � � � � � � � $$If a$gd�� $If A B � kd $$If �l � �gִ ����C���%*1~6 " % h h + � � T t ��0 � � � � � � ��6� � � � � � � � � � �� � � � � � � � �� � � � � � � � �� � � � � � � � �4� 4� l a� yt�6 B R S T U e f � � � � � � � � � � $$If a$gd�� $If � � � kd $$If �l � �^ִ ����C���%*1~6 " % h h + � � T t ��0 � � � � � � ��6� � � � � � � � � � �� � � � � � � � �� � � � � � � � �� � � � � � � � �4� 4� l a� yt�6 � � � t u v w � � � � e _ _ _ $If � kd: $$If �l � ���F ��� `~6 e g 4 t ��0 � � � � � � ��6� � � � � �� � � �� � � �� � � �4� 4� l a� yt�6 $If gd�~ � � � � � , p j d X X X X X X j $$If a$gdMDP $If $If � kd� $$If �l � �F ��� `~6 e g 4 t ��0 � � � � � � ��6� � � � � �� � � �� � � �� � � �4� 4� l a� yt�6 , . � � � 9 3 * * $If gd�]� $If � kd� $$If �l � ֈ ���,��i~6 # u h h m t ��0 � � � � � � ��6� � � � � � � �� � � � � � �� � � � � � �� � � � � � �4� 4� l a� yt�6 � � � � � � � � � � � $If $If $If gd�, � � � � � 6 * $ $ $If $1$G$If gd�� � kd� $$If �l 4� �?ֈ ���,��i~6`# u h h m t ��0 � � � � � � ��6� � � � � � � �� � � � � � �� � � � � � �� � � � � � �4� 4� l a� yt�6 � � � � � � � � * � kd� $$If �l 4� �?ֈ ���,��i~6�# u h h m t ��0 � � � � � � ��6� � � � � � � �� � � � � � �� � � � � � �� � � � � � �4� 4� l a� yt�6 $If $If � � � � � � � � � � $If $1$G$If gd�� 6 0 0 ' $If gd�]� $If � kd� $$If �l 4� �$ֈ ���,��i~6�# u h h m t ��0 � � � � � � ��6� � � � � � � �� � � � � � �� � � � � � �� � � � � � �4� 4� l a� yt�6 p q r s t � � � � � $If t u v � 6 * ! $If gd�� $1$G$If gd�� � kd� $$If �l 4� ��ֈ ���,��i~6`# u h h m t ��0 � � � � � � ��6� � � � � � � �� � � � � � �� � � � � � �� � � � � � �4� 4� l a� yt�6 � � � � � � � � � � 0 � kdt $$If �l 4� ��ֈ ���,��i~6�# u h h m t ��0 � � � � � � ��6� � � � � � � �� � � � � � �� � � � � � �� � � � � � �4� 4� l a� yt�6 $If � � y z { | } � � � � � � $If $1$G$If gd�� } ~ � � 8 2 ) $If gd�]� $If � kdn $$If �l 4� ֈ ���,��i~6�# u h h m t ��0 � � � � � � ��6� � � � � � � �� � � � � � �� � � � � � �� � � � � � �4� 4� l a� yt�6 � � � � � � � � $If $If gd� � $If gdrV� � � 8 , &